In recent years, therapies including direct puncture and biopsy in the medical field have been numerously performed, but in such cases, hemorrhage is inevitably induced, and it is clinically very important to stop the bleeding promptly. Since direct puncture or biopsy damages the blood vessels, hemorrhage from the injured site is inevitably caused, and if this bleeding continues for many hours, death may result. Accordingly, it is important to stop such bleeding promptly and surely.
However, no fully satisfactory hemostatic agent for such bleeding is known at present. That is, no hemostatic agent is known that can stop the bleeding from the injured site to the lacuna (pit) produced at the body-tissue or viscera by puncture or biopsy by easy filling of the lacuna with sol-like substance.
Reasons why such hemostatics have not so far been produced is that, according to the general theories of hemostatic therapy, it is to be better in the use of hemostatic materials under dry state, or that it is necessary to apply strong compression to the bleeding site.
In view of the above theories, it would never be favorably considered to use a sol-type agent for administration of hemostatics, and thus sol-type has never been considered to exert an appropriate hemostatic effect, and thus a sol-type agent has not been adopted for actual clinical practices. At present, for the hemostasis of the above mentioned bleeding, a rod-like material referred to as a "sounding" or inner tube of a biopsy needle or puncture needle is inserted to obtain physical stoppage of the bleeding hemostasis by forming a blood clot. Such a method requires a long time for completing hemostasis, and sometimes complete hemostasis cannot be obtained; that is, even when the hemostatic function of the patient is normal, it is not certain that complete hemostasis will be achieved even after continuing compression for 10-15 minutes. Further, it is not certain that the accident (accidental death) due to the bleeding (after bleeding) for a long time will be prevented. Moreover, the above technique may not achieve hemostasis in patients with reduced hemostatic function.
In the patient with reduced hemostatic function, there may be the case that hemostasis cannot be achieved and that the direct puncture and biopsy themselves should be abondoned.
Accordingly, the production of a hemostatic agent for obtaining prompt and complete hemostasis has been eagerly waited.
For obtaining such hemostatic agents, there are several types of techniques.
U.S. Pat. No. 4,265,233 refers to the exerting effect of fixing Factor XIII with thrombin to gelatin as a wound heeling material by accelerating the formation of insoluble fibrin; however, there is no mention of the hemostatic effect.
Trans. Am. Soi. Artif. Intern. Organs, Vol. XXVIII, 1982, pp464-468 and J. J. Artificial Organs (Jinko Zoki), Vol. 10, No. 6, 1981, pp1079-1082; Vol. 11, No. 6, 1982, pp958-961 describes the use of the gelatin material on which Factor XIII and thrombin are fixed as a suitable occulding material for transcatheter embolization; that is, an absorbable gelatin sponge (e.g., Spongel, trademark of Yamanouchi Pharm. (5.times.2.5.times.0.5 cm)) is fixed with thrombin and Factor XIII, then sliced, followed by mixing with contrast medium to form a sol-material, and using it as occulding material. However, this method accelerates insoluble fibrinformation by infusing the material into the blood vessel through an angiographic catheter. Thus, it does not suggest the performance of hemostasis by applying this agent for bleeding at a lacuna-site from the injured blood vessel by administration into micro-lacunae or pits (pores) occurring in the tissues or viscera. In the above mentioned J. J. Jinko Zoki, Vol. 11, No. 6, 1982, p.959, it is simply noted that it is applicable as a topical hemostatic material among its possibilities for clinical application. Whereas the administration method estimated from this phrase is similar to the usual administration method of Spongel (trademark) used as carrier, that is, this material formed in the shape of a dry cuboid is pressee and attached on the bleeding site, and it does not contain any hint of a method to treat the hemorrhage after an operation with direct puncture or biopsy. As mentioned in the above, by the conventional techniques, there is no review and no clarification of the optimum state for hemostasis in the bleeding after direct puncture and/or biopsy.